To Assess The Patient Preference for Goserelin Microsphere Versus Goserelin Implant in Patients With Prostate Cancer

Sponsored by The First Affiliated Hospital of Xiamen University

About this trial

Last updated 2 years ago

Study ID

GOMIMP

Status

Recruiting

Type

Interventional

Phase

Phase 2

Placebo

Accepting

18+ Years

Male

Trial Timing

Ended 6 months ago

What is this trial about?

The GOMIMP will be a Prospective, Randomized, Cross-over Trial to Explore the Patient Preference for Goserelin Microsphere (Zoladex®) Versus Goserelin Implant (LY01005) in Patients of Prostate Cancer

What are the participation requirements?

Inclusion Criteria

1. Male patients older than 18 years

2. Histologically confirmed prostate adenocarcinoma

3. Suitable for ADT treatment

4. ECOG≤2

5. Prior treatment without GnRH agonists

6. Expected survival >1 year

7. Good compliance

8. Adequate organ or bone marrow function as evidenced by:

* Hemoglobin >/= 10 g/dL

* Absolute neutrophil count >/=1.5 x 109/L,

* Platelet count >/=100 x 109/L,

* AST/SGOT and/or ALT/SGPT </=1.5 x ULN;

* Total bilirubin </=1.5 x ULN,

* Serum creatinine </=1.5 x ULN. If creatinine 1.0 - 1.5 xULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with creatinine clearance <60 mL/min should be excluded

Exclusion Criteria

1. Prior treatment with Zoladex, LY01005 or other GnRH agonists, while GnRH agonists for < 6 months and discontinued for more than 6 months were allowed

2. Diagnosed or suspected hormone-resistant prostate cancer, hypophysectomy, adrenalectomy, or pituitary lesions

3. A history of cardiovascular events, uncontrolled hypertension, gastrointestinal disease that interferes with treatment absorption, active viral hepatitis, or human immunodeficiency infection (HIV) within the past 6 months

4. Any medical conditions that the investigators believe make the patient ineligible to participate in the study